| CTRI Number |
CTRI/2023/09/057888 [Registered on: 20/09/2023] Trial Registered Prospectively |
| Last Modified On: |
15/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Parangipattai kashayam (Internal) and Sneha pottanam-Ottradam (External therapy) for Sirakambavatham (Cerebral palsy) |
|
Scientific Title of Study
|
Phase II Non-randomized clinical study on Sirakambavatham (Cerebral palsy) with the evaluation of siddha trial drug Parangipattai kashayam as Internal medicine and Sneha pottanam (Ottradam) as External therapy. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr T Priyanka |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College Arumbakkam Chennai |
| Address |
Post graduate Room No 25 Department of Kuzhanthai Maruthuvam
Government Siddha Medical College Arumbakkam
Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
8344008805 |
| Fax |
|
| Email |
priyankasiddha92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr C Shanmuga Priya |
| Designation |
Lecturer |
| Affiliation |
Government Siddha Medical College Chennai |
| Address |
Post graduate Room No 25 Department of Kuzhanthai Maruthuvam
Government Siddha Medical College Arumbakkam
Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9445661808 |
| Fax |
|
| Email |
cspriya2004@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr T Priyanka |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College Arumbakkam Chennai |
| Address |
Post graduate Room No 25 Department of Kuzhanthai Maruthuvam
Government Siddha Medical College Arumbakkam
Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
8344008805 |
| Fax |
|
| Email |
priyankasiddha92@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College Arumbakkam
Chennai |
|
|
Primary Sponsor
|
| Name |
Government Siddha medical college |
| Address |
No 6 Anna Arch Road
NSK Nagar
Arumbakkam
Chennai 600106 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr T Priyanka |
Government Siddha Medical College |
Room No, 25,
Department of Kuzhanthai Maruthuvam
Aringar Anna Government Hospital
NSK Nagar
Arumbakkam
Chennai
TAMIL NADU |
8344008805
priyankasiddha92@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G800||Spastic quadriplegic cerebral palsy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Parangipattai Kashayam (Internal) and Sneha pottanam-Ottradam (External therapy) |
Parangipattai kashayam 5 to 10 ml twice a day for 48 days and External therapy of Sneha pottanam-Ottradam on affected area for 48 days. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Delay in gross motor and fine motor milestones.
Delay in intellectual and cognitive functional development.
Abnormal muscle tone and reflexes.
Spastic quadriplegic cerebral palsy |
|
| ExclusionCriteria |
| Details |
Children above 12 years.
Patient with severe seizure disorder.
Patient with severe serious illness.
CP with other congenital associated disorders.
Autism spectrum disorders.
Mixed type of cerebral palsy.
Ataxic/Dyskinetic/Athetoid/Choreoathetoid/Dystonic cerebral palsy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is mainly assessed by reduction in clinical symptoms |
48 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| It is assessed by comparing the sensory functions connecting parameters & improvement in motor parameters and fine motor functions of the upper limb. |
48 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
05/10/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a single Non-Randomized Open Clinical Trial to study the safety and efficacy of Siddha trial drug Parangipattai kashayam (Internal) is to be given about 5 to 10 ml twice a day for 48 days and External therapy of Sneha pottanam (Ottradam) on the affected area for 48 days. Clinical trial conducted after conducting Pre clinical study. The trial drug Parangipattai kashayam and external therapy Sneha pottanam (Ottradam) has mentioned in Pillaipini vagadam. During the trial study related data will be recorded and documented. After the completion of trial all data will be statistically analysed. |